Blockchain protocols in clinical trials: Transparency and traceability of consent

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing the collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we will built a consent workflow using a rising technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. Additionally, it removes the need for third parties, and gives participative control to the peer-to-peer users. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain; thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each revision of the protocol, consent was sought again. We obtained a single document, in a standard open format, that accounted for the whole consent collection process: timestamped consent status with regards to each version of the protocol. This document cannot be corrupted, and can be checked on any dedicated public website. It should be considered as a robust proof of data. In the future, we think that the complex data flow of a clinical trial can be tracked using Blockchain. Moreover, a blockchain core functionality, named Smart Contract, can help prevent clinical trial events not to happen in the right chronological order: including patients before they consented or analysing case report forms data before freezing the database. This will help reaching reliability, security, and transparency, and could be a consistent step towards reproducibility.

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Blockchain protocols in clinical trials: Transparency and traceability of consent

F1000Research ◽

10.12688/f1000research.10531.5 ◽

2018 ◽

Vol 6 ◽

pp. 66 ◽

Cited By ~ 16

Author(s):

Mehdi Benchoufi ◽

Raphael Porcher ◽

Philippe Ravaud

Keyword(s):

Clinical Trial ◽

Research Field ◽

Point Of View ◽

Case Report Form ◽

Complex Data ◽

Proof Of Concept ◽

Blockchain Technology ◽

Smart Contract ◽

Authentication System ◽

Core Functionality

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again. We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a consistent step toward reproducibility.

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Blockchain protocols in clinical trials: Transparency and traceability of consent

F1000Research ◽

10.12688/f1000research.10531.4 ◽

2017 ◽

Vol 6 ◽

pp. 66 ◽

Cited By ~ 8

Author(s):

Mehdi Benchoufi ◽

Raphael Porcher ◽

Philippe Ravaud

Keyword(s):

Clinical Trial ◽

Research Field ◽

Point Of View ◽

Case Report Form ◽

Complex Data ◽

Proof Of Concept ◽

Blockchain Technology ◽

Smart Contract ◽

Authentication System ◽

Core Functionality

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again. We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a consistent step toward reproducibility.

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Patient Perspective of Blockchain Technology in Clinical Trial Management: A Proof of Concept Study (Preprint)

Journal of Medical Internet Research ◽

10.2196/13597 ◽

2019 ◽

Author(s):

Julia Feldman ◽

Laura Pugliese ◽

Katrina Mateo ◽

Stan Kachnowski

Keyword(s):

Clinical Trial ◽

Patient Perspective ◽

Proof Of Concept ◽

Trial Management ◽

Concept Study ◽

Blockchain Technology ◽

Clinical Trial Management

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Application of Blockchain Technology in Online Education

International Journal of Emerging Technologies in Learning (iJET) ◽

10.3991/ijet.v13i10.9455 ◽

2018 ◽

Vol 13 (10) ◽

pp. 252 ◽

Cited By ~ 11

Author(s):

Han Sun ◽

Xiaoyue Wang ◽

Xinge Wang

Keyword(s):

Online Education ◽

Resource Sharing ◽

Data Encryption ◽

Internet Technology ◽

Chronological Order ◽

Digital Currency ◽

Blockchain Technology ◽

Smart Contract ◽

Digital Certificates ◽

Technical Principles

Blockchain is a data structure of data blocks arranged in chronological order. It is featured by decentralization, trustworthiness, data sharing, security, etc. It has been widely used in digital currency, smart contract, credit encryption and other fields. With the development of the Internet technology, online education, a novel education mode, has been greatly popularized. However, this education mode still faces many problems in course credibility, credit and certificate certification, stu-dent privacy, and course sharing. Through literature review and case analysis, this paper discusses the basic technical principles and application features of blockchain technology, and proposes a solution to the problems of online educa-tion based on blockchain technology. The blockchain technology can store learn-ing records in a trusted, distributed manner, provide credible digital certificates, realize learning resource sharing with smart contract, and protect intellectual property through data encryption. The research shows that the integration of blockchain technology is a promising trend in the development of online educa-tion.

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Blockchain: A Tale of Two Applications

Applied Sciences ◽

10.3390/app8091506 ◽

2018 ◽

Vol 8 (9) ◽

pp. 1506 ◽

Cited By ~ 4

Author(s):

Micael Ferreira ◽

Sven Rodrigues ◽

Catarina Reis ◽

Marisa Maximiano

Keyword(s):

Proof Of Concept ◽

Relevant Issue ◽

Blockchain Technology ◽

Smart Contract ◽

Major Subject ◽

The Media ◽

Concept Application ◽

The Moment ◽

Forward Process

Bitcoin continues to get more and more attention from the media, mainly because of the volatility of its value and insignificantly associated with the technological innovation. This cryptocurrency is supported by an immutable database and is distributed throughout a network of thousands of nodes, known as Blockchain. One way to ensure that all the concepts behind the Blockchain technology and infrastructure are seized is to conduct the development of one of the most popular context applications for it: a wallet for well-known cryptocurrencies. Yet Another Bitcoin Wallet (YABW) is a hybrid application available for both Android and iOS, which was developed with the Ionic and Angular frameworks. This application communicates with Bitcoin Blockchain to send, receive and store bitcoins; provides a set of features focused on security and user experience, and is available on the Play Store and Apple Store. A rather relevant issue that is becoming a major subject of current research is the application of the Blockchain infrastructure to other contexts that are neither directly connected to cryptocurrencies, nor are finance related. The implementation of a proof-of-concept application proposes the use of a blockchain for a specific case study: the exchange of meal vouchers of an institution amongst students. This is achieved using the decentralized platform Ethereum, which allows us to create a Smart Contract using the Solidity programming language to create a token that follows the Ethereum Request for Comment (ERC), the ERC-20 standard and represents the meal vouchers. This second application uses the architecture defined for YABW, reusing major components and custom developing specific modules to enhance the required features. There is still a lot of research to be done on the non-financial applicability of the Blockchain infrastructure and technology, but for the moment, we have left further evidence that it is possible and is a relative straight-forward process to accomplish from the technological perspective.

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Patient Perspective of Blockchain Technology in Clinical Trial Management: A Proof of Concept Study (Preprint)

10.2196/preprints.13597 ◽

2019 ◽

Author(s):

Julia Feldman ◽

Laura Pugliese ◽

Katrina Mateo ◽

Stan Kachnowski

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Patient Perspective ◽

Health Data ◽

Management Tool ◽

Proof Of Concept ◽

Trial Management ◽

Concept Study ◽

Blockchain Technology ◽

Clinical Trial Management

BACKGROUND Blockchain is a technology that has emerged over the past 12 years with the potential to heighten security, data provenance, immutability and create a ‘patient centered experience’ when used in clinical trials. Although much of the recent literature discusses the potential for blockchain to benefit patients in these trials, no IRB-approved, independent study, has evaluated a blockchain-enabled clinical trial management tool from the patient perspective. OBJECTIVE The objective of this study was to determine the usability and feasibility of a blockchain-enabled clinical trials management platform with a connected activity tracker and blood pressure monitor through the perspective of patients. Specifically, this study aimed to assess the ability of the blockchain-enabled platform to support electronic consenting, participants’ engagement and compliance to study activities in the one-week period, and to assess the participants’ ability to successfully use and transmit health data via the connected devices. METHODS A rapid proof of concept study of a blockchain software platform used for patient eConsent, engagement and management in clinical trials was conducted. Participants were recruited using digital flyering on online forums (e.g. Craigslist) and by contacting participants from previous studies by the authors. To be eligible participants had to be native English speakers aged 18-75 who: 1) have been diagnosed with at least one chronic condition, and 2) possess an Android or iOS Smart Phone. Once enrolled, participants used the platform (webpage and smartphone app) and activity trackers (a Fitbit™ and iHealth™ devices) for a one-week period. Adherence data as well as perceptions of the platform were collected via semi-structured interviews and surveys at baseline and endline visits. Audio-recorded interviews were professionally transcribed and systematically coded. RESULTS 15 chronically ill individuals with a mean age of 37.7 participated. Themes on opinions of the key properties of the blockchain technology emerged. Participants expressed that they valued transparency features of the blockchain tool because it would make doctors more accountable and potentially more cautious about the care they provide, which was especially important for patients with many doctors. Participants valued the ability to easily access, share and collect data remotely via the app because it saves money and time. Participants were highly interested in sharing their health records for clinical trials or being “matched” into trials. The heightened security of blockchain did not emerge as a major value because most expressed that they weren’t worried about keeping their health data secure. CONCLUSIONS Testing highlighted participants’ overall positive experience with the tool and trust that it could support their adherence to activities in the clinical trial, and that they would recommend the application be used in future studies. Participants believed that blockchain can improve the quality of care in clinical trials and were open to adopting it.

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Whatever Happened to the Cambridge Capital Theory Controversies? (With comments by L. Pasinetti, F. Fisher, J. Felipe and J. McCombie, R. Greenfield and reply by the authors)

Voprosy Ekonomiki ◽

10.32609/0042-8736-2009-8-4-27 ◽

2009 ◽

pp. 4-27

Author(s):

A. Cohen ◽

G. Harcourt

Keyword(s):

Economic Theory ◽

Economic Thought ◽

Point Of View ◽

Chronological Order ◽

Capital Theory

The article written by the well-known theorists and historians of economic thought contains a detailed overview of the Cambridge capital controversy, which had raged from the mid-1950-s through the mid-1970-s. The authors track the origins of the controversy and cover arguments of both sides in chronological order. From their point of view, the discussion hasnt been resolved, and its main underlying aspects were ideological beliefs and fundamental methodological controversies on the nature of equilibrium and on the role of time in economic theory. The article is published with comments written by other leading theoreticians.

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The Potential Of Blockchain Technology To Change International Mobile Roaming Business Model

ACMIT Proceedings ◽

10.33555/acmit.v5i1.70 ◽

2019 ◽

Vol 5 (1) ◽

pp. 15-22

Author(s):

Ardian Thresnantia Atmaja

Keyword(s):

Business Model ◽

Current Situation ◽

Business Value ◽

Third Party ◽

Fundamental Aspect ◽

Clearing House ◽

Blockchain Technology ◽

Smart Contract ◽

Target Architecture ◽

Architecture Development

The key objectives of this paper is to propose a design implementation of blockchain based on smart contract which have potential to change international mobile roaming business model by eliminating third-party data clearing house (DCH). The analysis method used comparative analysis between current situation and target architecture of international mobile roaming business that commonly used by TOGAF Architecture Development Method. The purposed design of implementation has validated the business value by using Total Cost of Ownership (TCO) calculation. This paper applies the TOGAF approach in order to address architecture gap to evaluate by the enhancement capability that required from these three fundamental aspect which are Business, Technology and Information. With the blockchain smart contract solution able to eliminate the intermediaries Data Clearing House system, which impacted to the business model of international mobile roaming with no more intermediaries fee for call data record (CDR) processing and open up for online billing and settlement among parties. In conclusion the business value of blockchain implementation in the international mobile roaming has been measured using TCO comparison between current situation and target architecture that impacted cost reduction of operational platform is 19%. With this information and understanding the blockchain technology has significant benefit in the international mobile roaming business.

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LA ORIENTACIÓN FAMILIAR PARA LA PREVENCIÓN DEL CONSUMO DE DROGAS EN LOS ALUMNOS DEL TERCER AÑO DE BACHILLERATO

Revista Cognosis. ISSN 2588-0578 ◽

10.33936/cognosis.v3i5.1527 ◽

2018 ◽

Vol 3 (5) ◽

pp. 39

Author(s):

Yéssica Elizabeth Barreto Macías ◽

Colón Avellán Velásquez

Keyword(s):

High School Students ◽

Drug Use ◽

Interpersonal Relationships ◽

Negative Influence ◽

Point Of View ◽

Family Counseling ◽

High Rate ◽

School Students ◽

Family Orientation ◽

The Right

El actual trabajo afronta una de las problemáticas más apremiantes de los actuales momentos como es el alto índice de dispendio de drogas en las Instituciones Educativas, que afectan considerablemente a la sociedad ecuatoriana. Su objetivo es analizar los lineamientos que permitan mejorar la orientación familiar, y desarrollar relaciones interpersonales apropiadas que fomenten la unión familiar, practicar principios, fomentar valores morales, y que los jóvenes aprendan a decir “no” ante una eventual propuesta de consumir compuestos prohibidos, que lo único que se consigue es materializarse en un estado no idóneo ante la comunidad, considerar que las consecuencias para la salud son devastadoras, personas que a temprana edad padecen de enfermedades que en muchas ocasiones son gravísimas, causando malestar no solamente propio sino a la familia. Puedo mencionar como aporte de este artículo; y en base a resultados establecidos que resulta primordial e importante mantener la asistencia de un profesional especializado en psicología, diálogos científicos y motivadores, conjuntamente con atención médica provocarán en la persona afectada la erradicación del consumo de drogas. Constan muchos factores que causan gran influencia negativa en las familias, partiendo de que actualmente el mundo vive la tendencia del consumismo lo que influye en sobremanera que exista menos dialogo en el hogar, la aparición de la tecnología es otra de las situaciones adversas. Los profesionales encargados de brindar orientación familiar deben considerar siempre, que el comportamiento del ser humano debe ser comprendido desde el punto de vista de su forma de pensar, solo así se desarrollara una cultura que permita a las familias tomar las decisiones acertadas al momento de formar a sus hijos, lo que en un futuro se evidenciará como seres útiles a la sociedad. PALABRAS CLAVE: Consumo de drogas; orientación familiar; valores morales. FAMILY COUNSELING, FOR THE PREVENTION OF DRUG USE IN THIRDYEAR HIGH SCHOOL STUDENTS ABSTRACT The current work addresses one of the most pressing issues of current times such as the high rate of drug use in educational institutions, which greatly affect Ecuadorian society. Its objective is to analyze the guidelines for improving family orientation, and develop appropriate interpersonal relationships that promote family unity, value the principles, and that young people learn to say "no" to a possible proposal to use prohibited drugs, that the only thing that is achieved is to materialize in an unsuitable state before the community, to consider that the consequences for health are devastating, people who at an early age suffer from diseases that in many occasions are very serious, causing discomfort not only their own but also the family. I can mention as contribution of this article; and based on established results that it is essential and important to maintain the assistance of a professional specialized in psychology, scientific and motivational dialogues, together with medical care, will cause the affected person to eradicate drug use. There are many factors that cause great negative influence on families, based on the fact that the world currently lives the trend of consumerism which greatly influences that there is less dialogue at home, the emergence of technology is another of the adverse situations. The professionals responsible for providing family counseling should always consider that the behavior of the human being should be understood from the point of view of their way of thinking, only in this way will a culture be developed that allows families to make the right decisions when forming to their children, which in the future will be evident as useful beings to society. KEYWORDS: drug use; family orientation; moral values.

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